Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients. (eCare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04739696
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : May 14, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This randomized control trial will investigate the ability of an effective stress management psychoeducation program for employed caregivers to mitigate psychological distress and pathophysiology in spousal or partnered caregivers of patients' diagnosis with a solid tumor cancer of any stage. It is expected that improving caregiver status will have reduced depressive symptoms.

Condition or disease Intervention/treatment Phase
Breast Cancer Lung Cancer Colon Cancer Solid Tumor, Adult Behavioral: PEPRR Behavioral: Pep-Pal Not Applicable

Detailed Description:

Specific Aims

  • Evaluate the impact of PsychoEducation Paced Respiration and Relaxation (PEPRR) delivered remotely as Virtual-PEPRR or online as Pep-Pal on caregivers employed at the time of their patient's cancer diagnosis and preselected based on high self-reported distress.
  • Evaluate patient psychological status and healthcare utilization in patients whose caregivers received Virtual-PEPRR or Pep-Pal versus TAU
  • Evaluate whether caregivers employment outcomes are associated with patient symptom management as an exploratory question.

OUTLINE: Caregivers are randomized to one of 3 groups (1:1:1) 1) Treatment as usual (TAU), 2) Virtual-PEPRR, or 3) Pep-Pal.

  • Group I (treatment as usual [TAU]): Caregivers randomized to TAU will not participate in the stress management interventions. The TAU condition for this study takes into account published recommendations for an adequate representation of TAU. All participants regardless of randomization will be encouraged to use available psychological resources.
  • Group II (Virtual PsychoEducation Paced Respiration and Relaxation [Virtual-PEPRR]): Caregivers participating in the Virtual-PEPRR intervention will consist of eight 60-75 minute video or telephone sessions. Each Virtual-PEPRR session will be devoted to a specific topic with the goal of assisting the caregiver in developing and applying stress-management skills both in caregiving as well as in their work setting. Sessions include problem-solving, identifying cognitive distortions, application of relaxation techniques such as the emWave2, acquiring new coping skills, utilizing social support, and establishing appropriate goals, and finding support. All caregivers in Virtual-PEPRR will be provided a Caregiver Workbook that includes information about the session topics and homework assignments.
  • Group III (Pep-Pal): Pep-Pal is a mobilized version of Virtual-PEPRR. Pep-Pal includes eleven web-based video modules replicate essential components of each session of Virtual-PEPRR, but in shorter format (<20 minute. duration) with engaging relaxation exercises. The modules include learning skills in problem-solving, identifying cognitive distortions, using relaxation techniques, acquiring new coping skills, utilizing social support, establishing suitable goals, and finding support. Pep-Pal includes "Mini-Peps" which are video guided, 3-minute stress reduction exercises that the caregiver can access any time. Caregivers randomized to Pep-Pal will complete modules at times that are convenient and web-accessible by smartphone, tablet, laptop, or desktop computer. Caregivers can complete more than one module a week, repeat any session, and access the Mini-Peps as frequently as desired.

Caregivers and patients undergo psychosocial assessments prior to randomization, and at 3 months, 6 months, 9 months and 1 year after baseline. At each phase, caregivers and patients will complete battery of questionnaires that includes the Center for Epidemiological Studies-Depression scale (CES-D), the perceived stress scale (PSS), and the State-Trait Anxiety Inventory (STAI). Caregivers will be asked monthly to complete eight very short questions Patient-Reported Outcomes Measurement Information System (PROMIS). Additionally the patient will complete the MD Anderson Symptom Inventory each time while the caregiver completes questionnaires will cover details about how being a caregiver has affected their lives, details about employment, insurance and accommodations, general physical and mental well-being, and the impact Covid-19 has had on their lives. The patient and the caregiver will additionally complete a demographic questionnaire that includes questions regarding age, diagnosis, income, and other standard questions regarding nutrition, health behaviors, and health services utilization. At study completion, an exit questionnaire will address each subject's evaluation of the study and the group in which they were assigned.

Saliva and hair samples from caregivers will be collected every three months: baseline, 3 months, 6 months, 9 months and 1 year after baseline.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cancer Caregivers and Their Struggle(s) Between Work and Family
Actual Study Start Date : February 5, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
No Intervention: Caregiver Control
biomarker analysis; questionnaire administration; survey administration; treatment as usual
Experimental: Caregiver Intervention
biomarker analysis; questionnaire administration; survey administration; PsychoEducation Paced Respiration and Relaxation (PEPRR), which includes virtual one-on-one psychoeducation and stress management intervention.
Behavioral: PEPRR
Briefly presented in the following order, sessions will include: 1) Overview and Introduction to Stress Management 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with work and caregiver stress, 5) Strategies for maintaining energy and stamina with caregiver and work demands, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs to employers and your loved ones, and 8) Getting the support they need including work accommodations and/or legal protections (e.g., Family Medical Leave Act, Americans with Disabilities Act)
Other Names:
  • Virtual-PEPRR
  • PsychoEducation Paced Respiration and Relaxation

Experimental: Caregiver Self-Directed
biomarker analysis; questionnaire administration; survey administration; Pep-Pal web-accessible video modules of the psychoeducation and stress management intervention.
Behavioral: Pep-Pal
Pep-Pal program consisted of 11 sessions: 1) Introduction to stress management, 2) Stress and the mind body connection, 3) How thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty, 7) Managing changing relationships and communicating needs, 8) Getting the support they need; 9) Employment related challenges and resources for working caregivers; 10) Employment session one; 11) Employment session two




Primary Outcome Measures :
  1. Caregiver: Change in Center for Epidemiological Studies Depression Scale (CESD) [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months follow up ]
    Change in caregiver depressive symptoms. Center for Epidemiological Studies Depression Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.


Secondary Outcome Measures :
  1. Caregiver: Change in Spielberger State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up ]
    Change in caregiver anxiety. The "Spielberger State and Trait Anxiety Inventory" (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).

  2. Caregiver: Change in Perceived Stress Scale (PSS) [ Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up ]
    Change in caregiver perceived stress. The "Perceived Stress Scale" (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress.

  3. Caregiver: Health Care Utilization [ Time Frame: Baseline, 12 month follow up ]
    Caregiver electronic health records and supplemented by Colorado All Payer Claims Data and self-report

  4. Caregiver: Change in Adrenal Activity Over Time [ Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up ]
    Cortisol measured in hair will be used as a retrospective measure of activation of the hypothalamic pituitary adrenal axis.

  5. Caregiver: Change in Caregiver Telomere Length Over Time [ Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up ]
    Telomere length was assessed as a measure of cellular aging in blood samples from participants.

  6. Patient: Change in Center for Epidemiological Studies Depression Scale (CESD) [ Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up ]
    Change in patient depressive symptoms. Center for Epidemiological Studies Depression Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.

  7. Patient: Change in Spielberger State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up ]
    Change in patient anxiety. The "Spielberger State and Trait Anxiety Inventory" (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).

  8. Patient: Change in Perceived Stress Scale [ Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up ]
    Change in patient perceived stress. The "Perceived Stress Scale" (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress.

  9. Patient: Health Care Utilization [ Time Frame: Baseline, 12 month follow up ]
    Patient electronic health records and supplemented by Colorado All Payer Claims Data

  10. Patient: Change in MD Anderson Symptom Inventory (MDASI) [ Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month follow up ]
    Patient symptom management. the MD Anderson Symptom Inventory (MDASI) core scale, which assesses 13 symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, memory problems, lack of appetite, drowsiness, dry mouth, numbness, sadness, and vomiting) on a 0-10 scale.

  11. Caregiver: Employment status [ Time Frame: Baseline, 12 month follow up ]
    Caregiver self-report employment and weekly hours worked questions from Current Population Survey (CPS)

  12. Caregiver: Job Satisfaction [ Time Frame: Baseline, 12 month follow up ]
    Caregiver self-report job satisfaction. Job satisfaction is measured by a single-item assessment tool assessing whether or not the participant was satisfied with their current job. Satisfaction was measured on a 0-7 scale. Higher score indicates a higher level of satisfaction.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS (Meets all of the following criteria):

Patients who have a primary diagnosis of solid tumor cancer at any stage that are within 12 weeks +/- of starting treatment, which includes either infusion chemo- or immunotherapy, oral targeted agents, or both.

PATIENT CHARACTERISTICS:

  • A spouse or partner of the caregiver for at least a year
  • Live with caregiver
  • Able to read and speak the English language

CAREGIVER CHARACTERISTICS:

  • A primary caregiver for the patient with a diagnosis of solid tumor cancer
  • Spouse or partner of the patient for at least a year
  • Caregiver must live with patient
  • Must be available to fully participate in an intervention (Virtual-PEPRR or PepPal) if assigned
  • Must score 1 or greater on the PHQ-2 (depression) and/or GAD-2 (anxiety) during pre-screening.
  • Must be employed at the time of the patient's diagnosis for a minimum of 20 hours/week with plans to remain employed and working during their patient's treatment. Caregivers that were furloughed or laid off due to Covid-19 who are actively looking for work will be included.
  • Able to read and speak the English language
  • Willingness to use a Smartphone

Exclusion Criteria:

  • History of a psychiatric illness unrelated to their experience as a caregiver within the past 18 months
  • No serious medical condition likely to influence neuroendocrine parameters
  • No chronic steroid medication use (caregiver)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739696


Contacts
Layout table for location contacts
Contact: Crystal Natvig, MPH 303-724-9278 Crystal.Natvig@CUANSCHUTZ.EDU
Contact: Julia Byers, BS 303-724-4237 JULIA.BYERS@CUANSCHUTZ.EDU

Locations
Layout table for location information
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Cathy J Bradley, PhD University of Colorado Denver (Anschutz Medical Campus)
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04739696    
Other Study ID Numbers: 20-2458.cc
5R01CA231387-02 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
depression
stress
caregiving
anxiety
psychoeducation intervention
psycho-oncology
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases